Orthopedic devices utilizing rotary tensioning

ABSTRACT

An orthopedic device has at least one flexible or rigid frame member contoured to generally correspond to an anatomical limb. The device also includes a tightening system having a dial tensioning device and at least one cable and/or strap connected to the dial tensioning device. The dial tensioning device has a rotary ratchet permitting incremental adjustment of the cable and/or strap. Adjustment of the dial tensioner in a first direction secures the frame member to the limb.

This application claims the benefit of U.S. Provisional Application No.61/054,764, filed May 20, 2008, U.S. Provisional Application No.61/054,766, filed May 20, 2008, U.S. Provisional Application No.61/071,747, filed, May 15, 2008, and U.S. Provisional Application No.61/092,297, filed Aug. 27, 2008.

FIELD OF THE INVENTION

The present invention relates generally to the field of orthopedic orprosthetic devices and more specifically to orthopedic devices utilizingrotary tensioning that provides ease of donning, doffing, and adjustingwith the benefits of circumferential or wrap-around support andstabilization of the supported limb.

BACKGROUND

It is common that people, especially physically active and frail elderlypeople, experience a variety of limb injuries.

With regard to the foot and ankle, sprains to the calcaneofibular andanterior tabofibular ligaments often afflict a number of professionaland amateur athletes. To aid in the proper healing and treatment ofthese and other lower leg and foot injuries it is necessary that theaffected areas, as well as the surrounding tissue, be stabilized andimmobilized.

Physicians traditionally have treated, and still currently treat,injuries affecting lower leg extremities and the foot by fitting theinjured patient with the well-known, molded plaster or resin cast, whichis set around inner cotton or gauze lining. The placement of this typeof cast around the lower leg is time consuming, heavy, and costly.Further, this type of cast must not come into contact with water, whichmakes patient bathing difficult and time consuming. Additionally, if thecast needs to be removed for any reason, for example inspection orphysical therapy, a whole new cast must be prepared and applied.

Alternatively, lower leg walkers provide stabilization and support ofthe lower leg, including the ankle and foot, such that at least partialmobility may be maintained while an injury to the lower leg, ankle,and/or foot is in the process of healing. Further, in contrast to themolded plaster or resin cast, a lower leg walker can be removed by thepatient in order to bathe or for inspection of the injured limb by aphysician or practitioner.

Existing wrap-around or circumferential walkers can be bulky anddifficult and time consuming to don and doff. In particular, numerousstraps must be properly threaded through retaining rings and each strapindividually tightened in order to properly support and immobilize thelimb.

With respect to the knee, knee braces are widely used to treat a varietyof knee infirmities. Such braces may be configured to impart forces orleverage on the limbs surrounding the knee joint in order to relievecompressive forces within a portion of the knee joint, or to reduce theload on that portion of the knee. Moreover, in the event that kneeligaments are weak and infirm, a knee brace may stabilize, protect,support, unload, and/or rehabilitate the knee.

The knee is acknowledged as one of the weakest joints in the body, andserves as the articulating joint between the thigh and calf musclegroups. The knee is held together primarily by small but powerfulligaments. Knee instability arising out of cartilage damage, ligamentstrain and other causes is relatively commonplace since the knee jointis subjected to significant loads during the course of almost any kindof physical activity requiring the use of the legs.

A healthy knee has an even distribution of pressure in both the medialand lateral compartments of the knee. It is normal for a person with ahealthy knee to place a varus moment on the knee when standing so thatthe pressure between the medial and lateral compartments is uneven butstill natural.

One type of knee infirmity that many individuals are prone to having iscompartmental osteoarthritis. Compartmental osteoarthritis may arisewhen there is a persistent uneven distribution of pressure in one of themedial and lateral compartments of the knee. Compartmentalosteoarthritis can be caused by injury, obesity, misalignment of theknee, or simply due to aging of the knee.

A major problem resulting from osteoarthritis of the knee is that thesmooth cartilage lining the inside of the knee wears away. This leads toa narrowing of the joint space with the development of cysts anderosions in the bone ends. Because of the narrowing of the joint, bonecomes directly in contact with bone, and an uneven distribution ofpressure develops across the knee which may result in the formation ofbone spurs around the joint. All of these changes ultimately lead toincreasing pain and stiffness of the joint.

While there are no cures to osteoarthritis, there are many treatments.Individuals who have a diagnosis of isolated medial compartmentalosteoarthritis of the knee are confronted with a variety of treatmentoptions such as medications, surgery, and nonsurgical interventions.Nonsurgical interventions include the use of canes, lateral shoe wedges,and knee bracing.

Knee bracing is useful to provide compartment pain relief by reducingthe load on the compartment through the application of an opposingexternal valgus or varus moment about the knee joint. Unloading kneebraces have been shown to significantly reduce osteoarthritis knee painwhile improving knee function.

While known knee braces are successful at reducing pain or atstabilizing a knee joint, many users find these braces to be bulky,difficult to don and properly tighten, complicated to configure, anduncomfortable to wear. For these reasons, an embodiment described hereinhas streamlined features capable of providing relief for medial orlateral compartmental osteoarthritis, or functional stability of theknee that is easy to don and properly tighten, without the attendantdrawbacks of known unloading knee braces.

Accordingly, exemplary embodiments of a circumferential lower legwalker, and other orthopedic devices that alleviate or eliminate theabove mentioned drawbacks are described herein

SUMMARY

The orthopedic devices described herein may be, in exemplaryembodiments, an offloading, lower leg walker. It is also contemplatedthat other orthopedic devices may utilize similar configurations asdescribed below. Such additional orthopedic devices include but are notlimited to wrist braces, ankle braces, knee braces, cervical collars,elbow braces, and any other orthopedic devices having strappingconfigurations.

The embodiments of a lower leg walker described herein typically takethe form of a circumferential type walker, which provides support andstabilization to the lower leg by surrounding the lower leg, ankle, andfoot with an appropriate supporting superstructure. It will berecognized that the features described herein may have applicability toother lower leg walker configurations or other types of orthopedicdevices.

A first exemplary embodiment of a circumferential lower leg walker is inthe form of a clam-shell like walker that has a dorsal shell hinged toan anterior portion of the walker The dorsal shell is thus pivotablymoveable away from and towards the posterior and side shells of thewalker in order to open and close the walker in a clam-shell likemanner. This configuration provides easy insertion and removal of thelower leg from the walker. Further, a tightening mechanism is providedthat utilizes a lace or cable to simultaneously and incrementallytighten the components of the shell structure around the lower leg.Clearance holes can be provided in the shells to provide ventilation andweight savings.

In variations of the clam shell configuration walker, spacer fabrics orliners can be provided in some or all of the clearance openings in orderto provide a more comfortable or close fit between the walker and thelower leg.

In a further variation, connection or retaining points for the cable ofthe tightening mechanism can be covered by the shell portions when thewalker is in the closed configuration, so as to protect the retainingpoints and cable from damage.

In a further variation, the walker can have an open toe structure withthe hinge portion of the dorsal shell connecting to the opposed sideshell portions to surround the dorsal surface of the foot. An integralpump or inflation port can be positioned in a clearance hole of theshell to provide inflation to an inflatable liner or bladder. A fluidmay also be utilized to provide hot or cold therapy through theinflatable bladder. The bladder may be formed with multiple chambersdefined by welds therebetween with split openings in the welds toprovide ventilation. Soft coverings may be applied to the shells, or aseparate sleep cover may be utilized.

In a split dorsal shell embodiment of a circumferential walker, thedorsal shell is split into two or more components which are attached tothe walker shell via a cable, retainers, and the tightening mechanism.The split dorsal shells are selectively attached to each other via aconnector such as a zipper. When the dorsal shells are detached fromeach other, they may be flipped away from the opening of the walker toallow easy insertion of the lower leg therein.

In a side flap configuration of a circumferential walker, the dorsalshell is attached along one side to the walker shell via a cable,retainers, and the tightening mechanism. The dorsal shell is selectivelyattached to the walker shell along the other side via quick connectmechanisms. The quick connect mechanisms can be undone to allow thedorsal shell to be flipped away from the opening of the walker to alloweasy insertion of the lower leg therein.

In another embodiment, the dorsal shell is completely removable from thewalker. The tightening mechanism, cable, and retainers are all carriedby the dorsal shell. The retainers have a quick connect structure thatallows them to be selectively connected to the walker shell. Thus, thedorsal shell can be completely removed from the opening of the walker toallow easy insertion of the lower leg therein.

In a split back embodiment of a circumferential walker, the posteriorshell is formed in three pieces that are connected to each other viasuitable mechanisms, such as a strip of flexible material. Thetightening mechanism, cable, and retainers are all carried by portionsof the posterior shell. The wing portions of the posterior shell areselectively connected to the walker shell via quick connect mechanisms.Thus, the posterior shell can be completely removed or flipped away fromthe opening of the walker to allow easy insertion of the lower legtherein.

Similarly, a split dorsal shell configuration operates as justdescribed, with the functions of the dorsal and posterior shellsswitched so that the dorsal shell can be completely removed or flippedaway from the opening of the walker to allow easy insertion of the lowerleg therein.

An overlapping dorsal shell configuration of a circumferential walkerprovides overlapping dorsal shell portions that are selectively attachedto the walker shell via quick connect mechanisms. The tighteningmechanism, cable, and retainers are all carried by the overlappingdorsal shell portions. Thus, the dorsal shell can be completely removedor flipped away from the opening of the walker to allow easy insertionof the lower leg therein.

In each of the exemplary embodiments, the tightening mechanisms providequick and easy adjustment of the walker in order to provide the desiredamount of support and stabilization to the lower leg.

In other exemplary embodiments, various configurations of quicktightening mechanisms and arrangements are utilized to provide quick andeasy adjustment of the orthopedic device in order to provide the desiredamount of support and stabilization to the lower leg.

For example, an orthopedic device may include a first member (posteriorshell) and a second member (dorsal shell) corresponding to the firstmember. A rotary tensioning mechanism can be positioned on the secondmember and connected to at least one tensioning pulley positioned on thesecond member via at least one drive cable. At least one medial-lateraltensioning cable can extend between the tensioning pulley and the firstmember, such that rotation of the rotary tensioning mechanism in a firstdirection causes rotation of the at least one tensioning pulley to causethe at least one medial-lateral tensioning cable to draw the first andsecond members together.

Another exemplary embodiment of an orthopedic device disclosed hereinmay be of an unloading type knee brace, in accordance with theprinciples described in U.S. Pat. No. 7,198,610, granted Apr. 3, 2007,and U.S. publication nos. 2007/0185425A1, published Aug. 9, 2007,2006/0135904A1, published Jun. 22, 2006, 2006/0135903A1, published Jun.22, 2006, 2006/0135902A1, published Jun. 22, 2006, 2006/0135901A1,published Jun. 22, 2006, 2006/0135900A1, published Jun. 22, 2006, allcommonly assigned and all herein incorporated in the entirety byreference.

The underlying principals of the above referenced patent and patentapplication publications are discussed in detail within eachpublication. The present disclosure focuses on a variation of suchorthopedic devices disclosed in the above referenced patent and patentapplication publications. In particular, an orthopedic device in theform of a knee brace for stabilizing, protecting, supporting, unloading,and/or rehabilitating the knee is provided that utilizes a dialtensioning device to aid with tightening the force strap, and thatfurther utilizes pull tightening mechanisms to aid with tightening eachof the proximal and distal stability straps. The disclosed configurationprovides an improved knee brace that is easy to properly tighten for allusers via adjustment of the dial tensioning device and the pulltightening mechanisms.

Additional features of the knee brace may include padding or ventilatedpadding material provided as an interface between the proximal anddistal shells and a user's body, or between the stability straps and theuser's body. Further, openings, holes, or slots may be provided in anyor all of the shells and straps to aid with ventilation, reduce weight,and/or provide flexibility.

The numerous other advantages, features and functions of embodiments ofan orthopedic device having the features discussed herein will becomereadily apparent and better understood in view of the followingdescription and accompanying drawings. The following description is notintended to limit the scope of the orthopedic device, but instead merelyprovides exemplary embodiments for ease of understanding.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects, and advantages of the presentinvention will become better understood with regard to the followingdescription, appended claims, and accompanying drawings where:

FIG. 1 is a front side, lower perspective view of an embodiment of acircumferential walker according to the present disclosure;

FIG. 2 is a front side, upper perspective view of the embodiment of FIG.1;

FIG. 3 is a front side, lower perspective view of the embodiment of FIG.1 in an opened configuration;

FIG. 4 is a front side, lower perspective view of the embodiment ofFIGS. 1 and 4 with the laces or cables retracted;

FIG. 5 is a front side, lower perspective view of a variation of theembodiment of FIGS. 1-4;

FIG. 6 is a front side, lower perspective view of a variation of theembodiment of FIGS. 1-4;

FIGS. 7-11 represent side, front, and side perspective views of afurther variation of the embodiments of a circumferential walkeraccording to FIGS. 1-4;

FIG. 12 represents a side perspective view of an alternate embodiment ofa circumferential walker according to the present disclosure;

FIG. 13 represents a front side perspective view of an alternateembodiment of a circumferential walker according to the presentdisclosure;

FIG. 14 represents left and right front side perspective views of avariation of the embodiment of FIG. 13;

FIG. 15 represents a side perspective view of another embodiment of acircumferential walker according to the present disclosure;

FIG. 16 represents a rear side perspective view of a further embodimentof a circumferential walker according to the present disclosure;

FIG. 17 represents a side perspective view of another embodiment of acircumferential walker according to the present disclosure;

FIG. 18 represents left and right front side perspective views of avariation of the embodiment of FIG. 17;

FIG. 19 represents a side view of yet another variation of theembodiment of FIG. 17;

FIG. 20 represents a front view of the embodiment of FIG. 19;

FIG. 21 represents a side perspective view of another embodiment of acircumferential walker according to the present disclosure;

FIG. 22 represents left and right front side perspective views of avariation of the embodiment of FIG. 21;

FIG. 23 is a side perspective view of another embodiment of acircumferential walker according to the present disclosure;

FIG. 24 represents front and side views of a variation of thecircumferential walker shown in FIG. 23;

FIG. 25 illustrates a further variation of a strap configuration for usewith the circumferential walker shown in FIG. 23;

FIG. 26 is a side perspective view of another embodiment of acircumferential walker according to the present disclosure;

FIG. 27 is a front view of an embodiment of a dorsal shell for use withany suitable circumferential walker of the present disclosure;

FIG. 28 is a front side perspective view of a circumferential walkerutilizing a variation of the dorsal shell configuration of FIG. 27;

FIG. 29 is a perspective view of an embodiment of a circumferentialwalker utilizing a quick tensioning configuration;

FIG. 30 is a close up, partial perspective view of a variation of theembodiment of FIG. 29;

FIG. 31 is a close up partial view of a variation of a quick tensioningarrangement for use with the circumferential walker shown in FIG. 29;

FIG. 32 is a close up partial view of a variation of a quick tensioningarrangement for use with the circumferential walker shown in FIG. 29;

FIG. 33 is a perspective view of a tensioning pulley for use with theembodiments shown in FIGS. 29, 30, and 31;

FIG. 34 is a perspective view of a tensioning pulley for use with theembodiment shown in FIG. 32;

FIG. 35 is a perspective view of another tensioning pulley for use withthe embodiment shown in FIG. 32;

FIG. 36 is a perspective view of another tensioning pulley for use withthe embodiment shown in FIG. 32;

FIG. 37 is a perspective view of another tensioning pulley for use withthe embodiment shown in FIG. 32;

FIG. 38 is a front side perspective view of an embodiment of a kneebrace according to the present disclosure;

FIG. 39 is a further front side perspective view of the knee brace ofFIG. 38;

FIG. 40 is a front perspective view of the knee brace of FIG. 38;

FIG. 41 is a rear side perspective view of the knee brace of FIG. 38;

FIG. 42 is a magnified perspective view of a pull assembly of the kneebrace of FIG. 38.

It should be noted that the drawing figures are not necessarily drawn toscale, but instead are drawn to provide a better understanding of thecomponents thereof and are not intended to be limiting in scope, butrather to provide exemplary illustrations. It should further be notedthat the figures illustrate exemplary embodiments of orthopedic devicesand the components thereof and in no way limit the structures orconfigurations of the orthopedic devices and components thereofaccording to the present disclosure.

DETAILED DESCRIPTION

A. Environment and Context

Embodiments of an orthopedic device are provided for use in stabilizingand supporting the lower leg, foot, and ankle. In each of theembodiments, features that are provided one side of the device caneasily be provided on the other side of the device. In this manner, itis intended that any of the embodiments of the orthopedic devicedescribed herein may be used on either right or left lower legs, withany appropriate reconfiguration of components that is deemed necessaryfor the proper fit and function of the device for the purpose ofsupporting and stabilizing either the left or right lower leg.

Another embodiment of an orthopedic device is provided to reduce theeffect of osteoarthritis in a knee joint, or stabilize a knee joint thathas been weakened by injury or other infirmities and that is convenientto don and properly tighten for all users, and in particular, users whoare elderly or infirm. Although the illustrated embodiment shows thehinge positioned on the lateral side of the orthotic device and thestability straps positioned to extend around the medial side of theorthotic device, it will be understood that the orthotic device may beconfigured to reduce or cure both medial and lateral knee jointinfirmities, and thus, the hinge may be positioned on the medial side ofthe orthotic device and the stability straps may be positioned on thelateral side of the orthotic device. It will also be recognized that theembodiments of a knee brace of the present disclosure may be used witheither the right or left legs in order to provide relief for medial orlateral compartmental osteoarthritis, or functional stability for bothright side and left side knee joints.

The embodiment of the disclosure is particularly adapted for a humanknee joint, and may be dimensioned to accommodate different types,shapes and sizes of human joints and appendages. In addition,embodiments may be provided to orient principal forces exerted by strapsystems of the embodiments at any desirable location to treat kneeinfirmities.

For explanatory purposes, the knee brace embodiment described herein isdivided into sections which are denoted by general anatomical terms forthe human body. Each of these terms is used in reference to a human legwhich is divided in similar sections with a proximal-distal planegenerally extending along the meniscus of the knee between the femur andtibia.

The embodiment of the knee brace is also divided into anterior andposterior sections by an anterior-posterior plane. Theanterior-posterior plane generally corresponds to the coronal or frontalplane of a human leg. Each of the anterior and posterior sections isfurther divided about the center of the knee by a transverse orproximal-distal plane and median, sagittal or lateral-medial planes.

The anatomical terms described herein are not intended to detract fromthe normal understanding of such terms as readily understood by one ofordinary skill in the art of orthotics.

In each embodiment of the orthopedic devices described herein, a rotarytype tensioning mechanism may be used to provide ease of tightening thedevice. Exemplary rotary type tensioning mechanisms are described inU.S. Pat. No. 5,934,599, granted August 1999, U.S. Pat. No. 6,202,953,granted March 2001, and U.S. Pat. No. 6,289,558, granted September 2001,and U.S. publication nos. 2003/0204938, published November 2003,2006/0156517, published July 2006, 2007/0169378, published July 2007,2008/0060167, published March 2008, 2008/0060168, published March 2008,2008/0066272, published March 2008, 2008/0066345, published March 2008,2008/0066346, published March 2008, and 2008/0083135, published April2008, and all incorporated herein in the entirety by reference. Rotarytensioning devices as well as other suitable types of tensioning devicescan also be used. Further exemplary tensioning devices are described inU.S. Pat. No. 7,198,610, granted April 2007, commonly owned, and hereinincorporated in the entirety by reference.

The embodiments of the disclosure are adapted for supporting andstabilizing the lower leg or knee of human beings, and may bedimensioned to accommodate different types, shapes and sizes of humanjoints and appendages.

Exemplary materials and configurations for components of the orthopedicdevice, such as sole portions and shell portions, are described indetail in U.S. Pat. No. 5,078,128, granted January 1992, U.S. Pat. No.5,329,705, granted July 1994, U.S. Pat. No. 5,378,223, granted Jan. 3,1995, U.S. Pat. No. 5,464,385, granted November 1995, and U.S. Pat. No.5,761,834, granted June 1998, all assigned to Royce Medical Co. and allincorporated herein in the entirety by reference. Additional exemplaryconfigurations and materials are described in detail in U.S. Pat. No.7,303,538, granted December 2007, assigned to Össur hf, and incorporatedherein in the entirety by reference.

For further ease of understanding the embodiments of an orthopedicdevice as disclosed herein, a description of a few terms is necessary.As used herein, the term “dorsal” has its ordinary meaning and refers tothe top surfaces of the foot, ankle and foreleg or shin. As used herein,the term “plantar” has its ordinary meaning and refers to a bottomsurface, such as the bottom of a foot. As used herein, the term“proximal” has its ordinary meaning and refers to a location that iscloser to the heart than another location. Likewise, the term “distal”has its ordinary meaning and refers to a location that is further fromthe heat than another location. The term “posterior” also has itsordinary meaning and refers to a location that is behind or to the rearof another location. Lastly, the term “anterior” has its ordinarymeaning and refers to a location that is ahead of or to the front ofanother location.

The terms “rigid,” “flexible,” and “resilient” may be used herein todistinguish characteristics of portions of certain features of theorthopedic device. The term “rigid” is intended to denote that anelement of the device is generally devoid of flexibility. Within thecontext of support members or shells that are “rigid,” it is intended toindicate that they do not lose their overall shape when force isapplied, and in fact they may break if bent with sufficient force. Onthe other hand, the term “flexible” is intended to denote that featuresare capable of repeated bending such that the features may be bent intoretained shapes or the features do not retain a general shape, butcontinuously deform when force is applied. The term “resilient” is usedto qualify such flexible features as generally returning to an initialgeneral shape without permanent deformation. As for the term“semi-rigid,” this term is used to connote properties of support membersor shells that provide support and are free-standing, however suchsupport members or shells may have some degree of flexibility orresiliency,

Additionally, as used herein, the words “lace,” “cable,” and “wire” areused interchangeable and have their ordinary meanings and furtherdescribe an elongated member that is threaded through retention pointsand a tightening mechanism, and is used to provide tightening of theorthopedic device. Such “lace,” “cable,” and “wire” may refer torelatively long and relatively thin shaped metals or polymers, which maybe single strand or multi-strand, and which may include frictionreducing coatings thereon.

B. Detailed Description of a Clam-Shell Configuration Walker

A first embodiment of a circumferential lower leg walker having aclam-shell like configuration is shown in FIGS. 1-4. As can be seen fromthe figures, this embodiment opens and closes like a clam shell in orderto provide easy access to the interior of the device for ease of donningand doffing the device, in particular for donning and doffing the deviceonto an injured limb.

The clam-shell like walker 1000 is configured in an essentiallyone-piece construction to provide a sleek and low profile device for usein stabilizing and supporting the lower leg and includes a tighteningmechanism that provides incremental and simultaneous tightening of thewalker about the lower leg. Numerous advantages are obtained from such aconfiguration, such as lower weight, and less opportunity for the deviceto catch on external objects or clothing. Any weight savings will be asubstantial benefit, as a user must swing the mass of the walker, alongwith the leg, through the gait cycle. Additionally, the ease with whichthe tightening mechanism tightens the walker will aid users who may havetrouble manipulating numerous and more complicated strap arrangements.In particular, elderly or infirm persons will be able to properlytighten the walker with ease.

The walker 1000 includes a semi-rigid, or substantially rigid shellconfiguration that is formed to support and surround the lower leg,foot, and ankle of a user. The shell configuration can extend from thefoot and ankle up along the shin and tibia of the lower leg to a desiredpoint below the knee joint. Exemplary suitable materials for forming theshells can include metals, such as aluminum, carbon, compositematerials, such as carbon fiber/epoxy composites, glass fiber/epoxycomposites, or suitable plastic materials, such as thermoplastic orthermosetting polymers, fiber reinforced plastic, molded chopped fibers,or any other suitable material. Other exemplary materials include, butare not limited to, nylons, glass filled nylon, polypropylenes, vinyls,polyvinyl chlorides, high density polyethylene, epoxies, urethanes, andpolyesters.

The shell configuration includes a unitary dorsal shell 1004, aposterior shell 1006, and side shell portions 1014 extending along thelateral and medial sides of an outsole 1002. The side shell portions1014 extend around the anterior of the walker 1000 to define a toeprotector portion 1016. The outsole 1002 can be formed with suitabletread or other friction enhancing characteristics, and to provide theappropriate rocker sole type response associated with lower leg walkers.Any suitable material may be utilized to form the outsole 1002.

The dorsal shell 1004 is hinged to the toe protector portion 1016 viasuitable mechanisms. As shown, the hinge 1018 is formed via a flexibleplastic or elastomer, such as, for example, ethylene vinyl acetate(EVA). Of course, any suitable flexible material may be utilized,including silicone or natural or synthetic rubbers. Alternative hingemechanisms, such as pivot pins and sleeves, or piano or butterflyhinges, can also be used.

The hinge 1016 allows the dorsal shell 1004 to flip open away from theposterior and side shell portions 1006, 1014. In this manner, aclam-shell like configuration is obtained to provide easier insertion orremoval of an injured limb into or from the walker 1000.

Additionally, the dorsal shell 1004 can be formed with a further hingedportion 1020 between the shin/tibia portion and the foot portion inorder to provide a comfort fit between the walker 1000 and the ridge ofthe foot and ankle. The hinge portion 1020 can be constructed in thesame manner as the hinge 1018.

In order to further lighten the weight of the walker 1000, and/or toprovide ventilation, material can be removed from areas of the shellportions to provide clearance holes 1008. The clearance holes 1008 canbe formed in any of the shell portions and have any suitable size and/orshape.

In the exemplary configuration of the walker 1000 shown in FIGS. 1-4,each of the dorsal and posterior shells 1004, 1006 include wing portions1010, 1012 that extend from the respective shell portions towards theopposed shell portion. The wing portions 1010, 1012 wrap around the legin order to enclose and support the leg. The dorsal shell wing portions1010 extend generally towards the posterior of the walker 1000 and theposterior shell wing portions 1012 generally extend towards the anteriorof the walker 1000, such that corresponding dorsal and posterior wingportions generally overlap each other when the shells are broughttogether in a closed configuration and further define additionalclearance holes 1108 between them in the closed configuration. The wingportions 1010, 1012 also serve as anchor points for a lace or cable1032, and retainers 1034, as will be discussed in detail below.

The ease of donning and doffing the clam-shell like walker 1000 isfurther enhanced by the use of a tightening mechanism 1030 that allowseach portion of the brace to be simultaneously incrementally tightened,without the need for numerous cumbersome straps. The tighteningmechanism 1030 is positioned in a proximal area of the dorsal shell1004, but can be positioned in any suitable location on the walker 1000.

As illustrated in FIGS. 1-4, the tightening mechanism 1030 can be arotary type dial tensioner that, when rotated, either takes up or letsloose the cable 1032. The cable 1032 can be laced along the posteriorsurface of the dorsal shell 1004, or sandwiched within the dorsal shell1004 between two suitable materials, such that the cable 1032 remainsunobtrusive.

As shown in FIG. 4, the cable 1032 can extend from the dorsal shell 1004in the form of looped portions at different points along the shell. Aspreviously mentioned, the wing portions 1010 of the dorsal shell 1004can provide suitable areas from which the cable 1032 can extend. Whilethree such looped portions are shown along each side of the walker 1000,it will be recognized that fewer or more looped portions may be utilizedas needed.

In the open configuration, the looped portions of the cable 1032 can beminimized in size, by tightening or rotating the tightening mechanism1030, in order to prevent interference of the cable 1032 with insertionof the lower leg into the walker 1000.

As shown in FIG. 3, once the lower leg (not shown for ease ofillustration) is inserted into the walker 1000, the looped portions ofthe cable 1032 can be extended, by releasing, loosening, or rotating thetightening mechanism 1030. The looped portions of the cable 1032 can beengaged with the retainers 1034 positioned on the posterior wingportions 1012 in order to provide a “quick connect” type configuration.

To effectuate such a quick connect configuration, the retainers 1034 maybe provided in the form of hook type retainers with the protrudingportion of the hook extending from the retainer towards the posterior ofthe walker 1000. Thus, the looped portions of the cable 1032 can bewrapped or looped over the protruding portion of the hooks. Alternativeconfigurations may include any of the quick connect retainerconfigurations described herein below.

As shown in FIGS. 1 and 2, once the looped portions of the cable 1032have been appropriately engaged with the associated retainers 1034, thecable 1032 may be taken up to draw the dorsal shell 1004 into the closedconfiguration with the posterior shell 1006, such that the wing portions1010, 1012 overlap to encircle the lower leg. The tightening mechanism1030 is used to simultaneously tighten the cable 1032 throughout thewalker 1000, so that the entire walker is easily tightened around thelower leg, without the need for manipulating and tightening numerousstraps.

In order to remove the walker 1000 from the lower leg, the process isreversed, beginning with the release of the cable 1032 so that thedorsal shell 1004 can be flipped or pivoted away from the posteriorshell 1006. Once the shells are in the open configuration and spacedfrom each other, the lower leg can be removed from the walker 1000.

As can be seen from the illustration and the above discussion, the clamshell like configuration with the cable tightening system provides a lowprofile walker with ease of donning, doffing, and tightening foradjustment.

Additional features, such as inflatable liners with integrally attachedpumps, a foam midsole to control heel strike and roll over, and or afabric exterior covering for the shell portions may also be provided.

Additionally, the shell portions may be formed from appropriatelyresilient materials or have particular resilient portions that allow theshell portions to better conform to the geometry of the user's lowerleg. In such a case, the rigidity and stabilization for the support areprovided via the tightening of the cable about the resilient portions.

Further variations and embodiments are described below.

C. Detailed Description of a Variation of a Clam-Shell ConfigurationWalker

A variation of a clam-shell configuration lower leg walker is shown inFIG. 5. The walker 1100 can be made from the same materials as, issubstantially the same as, and functions in substantially the samemanner as the walker 1000 described above.

In particular, the walker 1100 includes an outsole 1102, a dorsal shell1104, a posterior shell 1106, and side shell portions 1114. Again,dorsal and posterior shell wings 1110, 1112 extend from the dorsal andposterior shells 1104, 1106. As above, clearance holes 1108 are providedin the shell portions.

The side shell portions 1112, 1114 extend around the anterior of thewalker 1100 to form a toe protector portion 1116. The outsole 1102 canextend over the side shell portions at the anterior of the walker 1100in order to provide further toe protection.

The dorsal shell 1104 is hinged to the anterior portion of the walker1100 at hinge portion 1118. A flexible hinge portion 1120 is alsopositioned along the midpoint of the dorsal shell 1120 in order toprovide a more comfortable fit.

A tightening mechanism 1130 is positioned on the dorsal shell 1104 inorder to tighten a cable 1132 that engages cable retainers 1134 asdiscussed in detail above.

In a variation from the embodiment of FIGS. 1-4, some of the clearanceholes can be filled with a liner or spacer fabric 1122 to provideaerated cushioning for the foot within the walker 1100. Exemplary spacermaterials are described in detail in U.S. publication nos. 2006/0135902,published June 2006, and 2007/0185425, published August 2007, bothincorporated herein in the entirety by reference. Such a spacer fabriccan provide additional comfort and a proper fit of the walker 1100.

A further variation of a clam-shell configuration walker is discussednext.

D. Detailed Description of a Further Variation of a Clam-ShellConfiguration Walker

Another variation of a clam-shell configuration lower leg walker isshown in FIG. 6. The walker 1200 can be constructed in substantially thesame manner and to function in substantially the same way as thepreviously discussed walkers 1000, 1100.

Specifically, the walker 1200 includes an outsole 1202, a dorsal shell1204, a posterior shell 1206, and side shell portions 1214, withclearance holes 1208 provided in the shell portions. Wing portions 1210,1212 extend from the dorsal and posterior shells 1204, 1206.

A toe protector portion 1216 is formed by the side shell portions 1212,1214 extending around the anterior of the walker 1200. The dorsal shell1204 is hinged to the anterior portion of the walker 1200 at hingeportion 1218. A flexible hinge portion 1220 is also positioned along themidpoint of the dorsal shell 1220 in order to provide a more comfortablefit.

A tightening mechanism 1230 is positioned on the dorsal shell 1204 inorder to tighten a cable that engages cable retainers as discussed indetail above. In a variation from the previous embodiments, the cableretainers of this embodiment can be positioned on the posterior wingportions 1212 such that they are covered or otherwise protected when thedorsal shell wing portions 1210 overlap the posterior wing portions1212. In this manner, the cable and the cable retainers are hidden fromview and protected when the shells are in the closed position.Accordingly, there is a reduced chance that the cable may accidentallycome free from the cable retainers during use or that the cable orretaining members may be damaged.

In a further variation from the previous embodiments, all of theclearance holes can be filled with a liner or spacer fabric 1222 toprovide aerated cushioning for the foot within the walker 1200. Asdiscussed above, such a spacer fabric can provide additional comfort anda proper fit of the walker 1200.

Another variation of a clam-shell configuration walker is discussednext.

E. Detailed Description of a Further Variation of a Clam-ShellConfiguration Walker

Another variation of a clam-shell configuration lower leg walker isshown in FIGS. 7-11. The walker 1300 can be constructed from similarmaterials and function in substantially the same way as the previouslydiscussed walkers 1000, 1100, 1200.

Walker 1300 includes a posterior shell 1306 that is formed as an opensuper structure support frame for surrounding the posterior portion ofthe lower leg and ankle, and the sides of the foot. The posterior shell1306 has an outsole 1302 attached to or integrally formed along theplantar surface. Lateral and medial wing portions 1312 extend from theposterior shell 1306 towards the anterior of the walker 1300. Side shellportions 1314 extend from a distal portion of the posterior shell andwing portions 1306, 1312. Clearance holes 1308 are provided forventilation, access, or to form cable retainers 1334, as will bediscussed below.

A dorsal shell 1304 is formed to substantially conform to the dorsalaspects of the lower leg, ankle, and foot, and to close the walker 1300in a clam-shell like manner, as previously discussed. In order toaccomplish the clam shell closing, the dorsal shell 1304 is connected tothe side shell portions 1314 in the anterior region of the side shellsvia hinges 1318. The hinges 1318 may be formed in any suitable manner,and as shown, are formed by pins rotating in the side shell portions1314.

Similarly to walkers 1000, 1100, 1200, a tightening mechanism 1330 ispositioned on the anterior surface of the dorsal shell 1304. A cable1332 is routed across the anterior surface of the dorsal shell 1304 inconnection with the tightening mechanism 1330 and retainers 1334.

As with the previous embodiments, the cable 1332 is looped throughretainers 1334 in a quick connect manner. Specifically, at least some ofthe retainers can be integrated into the clearance holes 1308, byforming the clearance holes 1308 in a U-shape with the projection of the“U” extending towards the posterior of the walker 1300 so that the cable1332 can be looped around the projection.

In this respect, the function and use of the walker 1300 is similar tothose previously discussed.

In addition to the features already described, the walker 1300 can haveone or more inflatable liners 1322. The inflatable liners can beinflated or deflated via associated inflation ports or integrallycarried pumps 1324. The inflation port or pump 1324 may be integrallycarried in a clearance hole 1308 of the posterior shell 1306. A singlepump can be provided to inflate all of the bladders simultaneously orindividually to different pressures, or each bladder may be providedwith an associated pump. The pumps are attached or carried by the walker1300 so that they are not easily misplaced.

Further, the pumps or inflation ports can be configured to be usablewith a fluid or liquid to provide hot and/or cold therapy,

The inflatable bladders can be configured to be ventilated by havingslits passing through welded portions of the bladders. The weldedportions can be used to create chambers within the bladders, and the useof more welded portions provides more chambers, as well as more slits toenable greater ventilation.

An additional feature is a midsole 1326 that can be formed withdifferent materials or geometries to control heel strike, toe off, andenergy return. An integrated adjustable heel platform or wedge can alsobe provided.

Further features may include providing a soft material covering over theshell portions or a sleep cover accessory to aid with preventingundesired contact with the hard surfaces of the walker 1300.

An embodiment of a split dorsal shell circumferential walker isdescribed next.

F. Detailed Description of a Split Dorsal Shell Configuration Walker

An embodiment of a split dorsal shell walker 1400 is shown in FIG. 12.The components of the walker 1400 can be formed from the same materialsas the previously discussed walkers.

Additionally, the walker 1400 has generally the same configuration asthe previously discussed walkers. In particular, a posterior shell 1406is formed having wing portions 1412 and side shell portions 1414 thatare integrated with or connected to an outsole 1402. The side shellportions 1414 and the outsole 1402 are configured to define a toeprotector portion 1416 at the anterior portion of the walker 1400.

A dorsal shell 1404 is formed in two dorsal shell portions 1410 that arereleasably connected to each other via connector 1428. As shown, theconnector 1428 can be a zipper connection that may be zipped andunzipped in a recognized manner. When the zipper is zipped, the dorsalshell 1404 has a configuration that substantially corresponds to thedorsal aspects of the lower leg, ankle, and foot, and wraps around theanterior portions of the posterior side shell wings 1412 and theproximal portions of the side shells 1414.

Cable retainers 1434 are provided on the exterior surface of the wingportions and side portions 1412, 1414, and on the interior surfaces ofthe dorsal shell portions 1410. A cable 1432 is threaded through theretainers 1434 and connected to a tightening mechanism 1430. A singlecable 1432 and tightening mechanism 1430 may be used, or one cable 1432and tightening mechanism 1430 may be used along each of the lateral andmedial sides of the walker 1400.

With the cable 1432 threaded through the retainers 1434, the dorsalshell portions 1410, are retained on the posterior shell wings and theside shells 1412, 1414. In order to place the user's lower leg withinthe walker 1400, the cable 1432 can be loosened by releasing thetightening mechanism 1430 and the zipper 1428 is unzipped so that thetwo dorsal shell portions 1410 can be detached from each other. Each ofthe dorsal shell portions 1410 can then be flipped open medially orlaterally, respectively, as shown by arrows A. Thus, the dorsal aspectof the walker 1400 can be opened for placement of the lower leg, ankle,and foot therein.

Once the lower leg (not shown for ease of illustration) is positionedwithin the walker 1400, the dorsal shells 1410 can be flipped back tocontact the dorsal aspects of the lower leg and reattached by zipping upthe zipper 1428. The cable 1432 can next be tightened by manipulating orrotating the tightening mechanism 1430 to pull the cable 1432 in thedirection indicated by arrow B. In this manner, when the cable 1432 istightened, the dorsal shells 1428 are pulled away from the midline ofthe walker 1400, as shown by arrows C.

As with previous embodiments, to remove the lower leg from the walker1400, the process is reversed.

Also like previous embodiments, an inflatable liner or bladder (notillustrated) can be placed within the walker 1400 to provide compressiontherapy and/or to aid with properly fitting the walker 1400 to the lowerleg. The inflatable liner can be inflated via the use of the integrateddual action micro pump 1424.

It can be seen that the split dorsal shell configuration provides analternate method of providing ease of donning, doffing, and tighteningthe walker, without the use of numerous and complicated strapconfigurations.

Variations of a side flap configuration for a circumferential lower legwalker are discussed next.

G. Detailed Description of a Side Flap Configuration Walker

Variations of a side flap configuration for a circumferential lower legwalker 1500 are shown in FIGS. 13 and 14. The walker 1500 can be formedfrom the same materials, in a similar configuration, and can function ina similar manner as previously discussed walkers.

Accordingly, the walker 1500 includes a posterior shell 1506 with wingportions 1512, and side shell portions 1514 attached to or integral withan outsole 1502, and extending around the anterior of the walker 1500 todefine a toe protector portion 1516.

Alternatively, as shown in FIG. 14, the side shell portions 1514 can endprior to the anterior portion of the walker 1500 and the toe protectorportion 1516 can be defined by a depending portion of the dorsal shell1504.

The dorsal shell 1504 is shaped and configured to correspond to thedorsal aspects of the lower leg, ankle, and foot, and to overlap thewing and side shell portions 1512, 1514. Along one side of the walker1500, the dorsal shell 1504 is connected to the walker 1500 via a cable1532 that is threaded through retainers 1534 arranged on the exteriorsurfaces of the wing and side shell portions 1512, 1514 and the dorsalshell 1504. The retainers can be fixed to the shells or removablyattached in any manner described herein. The cable is connected to atightening mechanism 1530 attached to a side of the walker 1500 fortightening and loosening in a manner discussed above.

Along the opposed side of the dorsal shell 1504 from the cable 1532, thedorsal shell is removably attached to the wing and side shell portion1512, 1514 along that side. The attachment may take the form of a zipperconnection as discussed above with respect to the walker 1400.

Alternatively, as shown in FIG. 14, the attachment may take the form ofquick connect connectors 1528 that are removably received in receiverportions 1538 in the wing and side shell portion 1512, 1514 along thatside. The receiver portions 1538 can include an enlarged portion and areduced portion such that the head of the connectors 1528 can be passedthrough the enlarged portion of the receiver portions 1538 and thenengaged with the reduced portion of the receiver portions 1538.Exemplary connectors and receiver portions are described in detail inU.S. publication nos. 2006/0135902, published June 2006, and2007/0185425, published August 2007, both previously incorporated hereinby reference.

In use, the cable 1532 can be loosened and the connectors 1528 or zipperreleased or unzipped so that the dorsal shell 1504 can be flipped overto open the walker 1500. The lower leg can then be placed therein andthe dorsal shell 1504 flipped back to cover the dorsal aspects of thelower leg and the connectors 1528 connected or the zipper zipped up toengage the dorsal shell 1504 to the wing and side shell portion 1512,1514 along that side.

The cable 1532 can next be tightened in the manner previously discussedto provide proper fit, support and stabilization to the lower leg. Ofcourse, the process can be reversed in order to remove the lower legfrom the walker 1500.

The number of connectors 1528 and lace retainers 1534 can be varied asdesired in order to provide the desired amount of strength and rigidityto the walker 1500.

A removable dorsal shell configuration walker is discussed next.

H. Detailed Description of a Removable Dorsal Shell Configuration Walker

The walker 1600 shown in FIG. 15 is a removable dorsal shellconfiguration that can be constructed from similar materials, in asimilar configuration, and to function in a similar manner as previouslydiscussed walkers.

Accordingly, an outsole 1602 is attached to or integrally formed with aposterior shell 1606 having wing and side shell portions 1612, 1614extending towards and around the anterior of the walker 1600 to form atoe protector portion 1616.

A wholly detachable and reattachable dorsal shell 1604 is configured tocorrespond to the dorsal aspects of the lower leg, ankle, and foot, andto overlap the wing and side shell portions 1612, 1614.

A tightening mechanism 1630, cable 1632, and retainers 1634 are arrangedalong the anterior surface of the dorsal shell 1604. Additionalretainers 1634 are positioned within loops formed by the cable 1632. Theloops and retainers 1634 extend away from the dorsal shell 1604 and theretainers 1634 include connector portions 1636 that are configured to beconnected to receiver portions 1638 positioned along the wing and sideshell portions 1612, 1614.

The connector and receiver portions 1636, 1638 can be configured asdiscussed above. Alternatively, the connections can be achieved viaother mechanisms, such as hook and loop connections or snap connectors.

The operation of the removable dorsal shell embodiment is as follows.The cable 1632 is loosened, and the retainers 1634 are disengaged fromthe walker 1600 so that the dorsal shell 1604 can be removed from thewalker 1600. Thus, the walker is in an open configuration which allowsthe lower leg to be inserted therein.

Once the lower leg is positioned within the walker 1600, the dorsalshell 1604 can be reattached to the walker 1600 by connecting theretainers 1634 to the walker 1600. Once the retainers 1634 have beenconnected, the cable 1632 can be tightened in a manner discussed above.

To remove the lower leg from the walker 1600, the process is reversed.

As can be seen, the complete removal of the dorsal shell from the walkerprovides a completely free opening in which to insert the lower leg intothe walker without causing pain to an injured limb. The tighteningmechanism also provides a quick manner of tightening the walker aroundthe lower leg in order to provide the necessary support andstabilization.

Next, a split back configuration lower leg walker is discussed.

I. Detailed Description of a Split Back Configuration Walker

A split back configuration walker 1700 is shown in FIG. 16 having asimilar construction from similar materials as previously discussed withregard to other walker embodiments.

The walker 1700 is configured as a rear entry walker with an insertionrecess defined between an outsole 1702 attached to or integrally formedwith side shells 1714 and a dorsal shell 1704 having wing portions 1710extending towards the posterior of the walker 1700. A toe protectorportion 1716 is formed on the anterior of the walker 1700 via the sideshells 1714 and the dorsal shell 1704.

Additionally, a completely removable, split posterior shell 1706 havingwing portions 1712 is arranged to surround and support the anterior ofthe lower leg. The posterior wing portions 1712 are attached to theposterior shell 1706 via suitable connection mechanisms, such as aflexible fabric or material to form an integral, split, posterior shellportion. The posterior wing portions 1712 are removably attached to thewing portions 1710 of the dorsal shell 1704 in any suitable mannerdiscussed herein above or below.

A tightening mechanism 1730 is carried on the proximal portion of theposterior shell 1706. Retainers 1734 are carried along the posteriorsurfaces of the posterior wing portions 1712. A cable 1732 is threadedthrough the retainers and connected to the tightening mechanism 1730.

In use, the cable 1732 is loosened and one or both of the posterior wingportions 1712 are detached from the wing portions 1710 of the dorsalshell 1704 in order to flip the posterior shell portion 1706 away fromthe opening or to completely remove the posterior shell portion 1706.

Once the opening is exposed, the lower leg is inserted therein, and theposterior wing portion or portions 1712 are reattached to the wingportions 1710 of the dorsal shell 1704. The cable 1732 can then betightened in a manner as previously discussed to provide the appropriatesupport and stabilization to the lower leg.

In order to remove the lower leg from the walker 1700, the process isreversed.

In view of the above, the complete removal of the posterior shell fromthe walker provides a completely free opening in which to insert thelower leg into the walker without causing pain to an injured limb. Thetightening mechanism also provides a quick manner of tightening thewalker around the lower leg in order to provide the necessary supportand stabilization.

In an alternate configuration, the posterior shell can be hinged to thewalker in a manner similar to those discussed above so that theposterior shell provides a clam-shell like configuration with the dorsalshell.

Next, variations of a split dorsal shell configuration walker arediscussed.

J. Detailed Description of a Split Dorsal Shell Configuration Walker

Variations of a split dorsal shell configuration walker 1800 are shownin FIGS. 17-20 having similar constructions from similar materials aspreviously discussed with regard to other walker embodiments.

Accordingly, an outsole 1802 is attached to or integrally formed with aposterior shell 1806 having wing portions 1812 and side shell portions1814 that can extend to form a toe protector portion 1816 at theanterior of the walker 1800.

It is noted that in alternate configurations shown in FIGS. 18-20 thatthe toe protector portion is not provided, or may be provided via adownward extending portion of the dorsal shell in a manner as discussedabove.

A completely removable split dorsal shell 1804 having wing portions 1810is configured to correspond to the dorsal aspects of the lower leg,ankle, and foot, and to overlap the wing and side shell portions 1812,1814.

As shown in FIG. 18, the wing portions 1810 are connected to the dorsalshell 1804 via a flexible fabric or material 1840. Of course, alternateconnection mechanisms, such as zippers or hook and loop fasteners mayalso be used.

For example, as shown in FIGS. 19-20, the connectors 1840 can be formedof respective sections of hook and loop material that are selectivelyengageable and disengageable from each other. Another variation in FIGS.19-20 is that the wing portions 1810 of the dorsal shell 1804 are formedin distinct proximal and distal portions. Further, at least one integralpump and/or inflation port 1824 is carried by the posterior shell 1812for inflating an inflatable bladder (not shown).

The dorsal shell of the embodiment of FIGS. 17-20 is similar inconfiguration to the split posterior shell of the embodiment of FIG. 16.Thus, the dorsal shell 1804 carries a tightening mechanism 1830 and thedorsal wing portions 1810 carry retainers 1834. A cable 1832 is threadedamong and between the retainers 1834 and connected to the tighteningmechanism 1830 for operation as previously discussed.

The dorsal wing portions 1810 are configured to be removably connectedto the posterior wing portions 1812 and side shell portions 1814 in anysuitable quick connect manner previously discussed. In particular, thedorsal wings 1810 can carry connectors 1836 that are received in slots1838 in the posterior wing portions 1812 and side shell portions 1814.

The operation of the split dorsal shell configuration walker issubstantially similar to the operation of the split back configurationwalker. The cable 1832 is loosened and one or both of the dorsal wingportions 1810 are detached from the walker 1800 to either flip thedorsal shell 1804 away from the opening or to completely remove thedorsal shell 1804.

Alternatively, the dorsal shell 1804 can be hinged to the walker 1800 ina manner discussed above.

Once the opening to the walker 1800 is exposed, the lower leg can beeasily inserted into the walker 1800. Next, the dorsal wing portions1810 are reattached to the walker 1800, and the cable 1832 is tightenedas previously discussed to provide the desired amount of support andstability to the lower leg.

In view of the above, the complete removal of the dorsal shell from thewalker provides a completely free opening in which to insert the lowerleg into the walker without causing pain to an injured limb. Thetightening mechanism also provides a quick manner of tightening thewalker around the lower leg in order to provide the necessary supportand stabilization.

Next, an overlapping dorsal shell configuration walker is described.

K. Detailed Description of an Overlapping Dorsal Shell ConfigurationWalker

Variations of an overlapping dorsal shell configuration walker 1900 areshown in FIGS. 21 and 22 having a similar construction, and made fromsimilar materials as previously discussed with regard to other walkerembodiments.

An outsole 1902 is attached to or integrally formed with a posteriorshell 1906 having wing portions 1912, and side shell portions 1914. Atoe protector portion 1916 is formed by the side shell portions 1914extending around the anterior of the walker 1900.

Alternatively, as shown in FIG. 22, there may be no toe protectorportion. Other alternatives include a toe protector portion formedintegrally depending from a dorsal shell portion.

As shown in FIGS. 21 and 22, a dorsal shell 1904 is configured tocorrespond to the dorsal aspects of the lower leg, ankle, and foot, andto overlap the wing and side shell portions 1912, 1914. The dorsal shell1904 is formed of at least two overlapping dorsal shell portions 1910.Variations can include multiple overlapping shell portions thatcorrespond to the dorsal surface of the shin and the foot respectively,for example. In such a variation, four dorsal shell portions wouldoverlap.

The overlapping dorsal shell portions 1910 can be attached to each othervia a flexible fabric or material 1940, or via a releasable connectionmethod as previously discussed. A tightening mechanism 1930 is carriedon one of the overlapping dorsal shell portions 1910 near the proximalend of the anterior surface thereof. Opposed retainers 1934 arepositioned on each of the overlapping dorsal shell portions 1910 and acable 1932 is strung between the retainers 1934 and connected to thetightening mechanism as discussed above. In a variation, the connector1940 can be eliminated, and connection between the overlapping dorsalshells 1910 can be achieved solely via the cable 1932, retainers 1934,and tightening mechanism 1930.

The dorsal shell 1904 can be removably attached to the posterior shellwing portions 1912 in any manner previously discussed. For example, eachof the overlapping dorsal shells 1910 can carry connector portions 1936thereon, which can be selectively engaged with received portions 1938along the posterior shell wing portions 1912, and side shell portions1914.

The method of operation of the walker 1900 is similar to previouslydiscussed methods. The cable 1932 is first loosened, and one or both ofthe overlapping dorsal shells 1910 are disengaged from the posteriorshell and side shells 1912, 1914 so that one of the shells 1910 can beflipped away from the opening or the dorsal shell 1904 can be completelyremoved from the opening. Thus, the lower leg can be inserted into thewalker 1900 with ease.

Once the lower leg is placed within the walker, the detached dorsalshell portions 1910 are reattached to the posterior shell and sideshells 1912, 1914, and the tightening mechanism 1930 is manipulated inorder take up the cable 1932. Thus, the walker 1900 is easily tightenedaround the lower leg to provide suitable support and stabilization,without the use of numerous and time consuming straps.

Further variations of circumferential walkers are discussed next.

L. Detailed Description of a Strap and Dial Tensioning ConfigurationWalker

As shown in FIGS. 23-25, an embodiment of a circumferential walkerutilizes a strap and dial tensioning configuration in order to achievequick and comfortable tightening of the walker around the lower leg,ankle, and foot.

As shown in FIG. 23, the walker 2000 includes a dorsal shell 2002 and aposterior shell 2004 for cooperation in a clamshell manner, aspreviously discussed.

Straps 2006 are positioned to extend across the dorsal shell 2002. Thestraps 2006 can be fixed at a first end to the posterior shell 2004along one side of the walker 2000. The opposed second end of the straps2006 extends across the dorsal shell 2002 for engagement with a dialtensioner 2012 in any manner discussed below, such that rotation of thedial tensioner 2012 causes tightening of the straps 2006, and hence,tightening of the walker 2000.

Returning to FIG. 23, each of the straps 2006 have a cable 2008connected to the second end thereof. The connection may be made in anysuitable manner recognized by a skilled artisan, such as via a rivet orscrew connection. Each of the strap cables 2008 are subsequentlyconnected to a main cable 2010 that is taken up and loosened via thedial tensioner 2012 in a manner as discussed above.

Thus, all of the straps 2006 can be tightened simultaneously via thedial tensioner 2012 in order to provide quick and comfortable tighteningof the walker around the lower leg, ankle, and foot.

As shown in FIG. 23, the dial tensioner 2012 can be detached from theposterior shell 2004 in order to aid with removal of the lower leg,ankle, and foot from the walker.

In the variation shown in FIG. 24, the dial tensioner 2012 is positionedin a distal portion of the posterior shell 2004, and cables 2008 areattached along a side of the dorsal shell 2002 at multiple attachmentpoints, prior to combining with the main cable 2010 that is taken up andloosened by the dial tensioner 2012.

In the variation shown in FIG. 25, each strap 2006 is connected todistinct dial tensioner 2012 in order to allow individual tightening ofeach strap 2006, which may provide additional control for tightening thewalker around the lower leg, ankle, and foot.

In a further variation, each of the straps can be connected together viaa rigid or semi-rigid element positioned along the second ends thereof,and a cable can be strung between the rigid or semi-rigid element and adial tensioner in order to provide simultaneous tensioning of thestraps.

Further variations of a circumferential walker utilizing a dialtensioning mechanism are described next.

M. Detailed Description of a Hook and Cable Dial TensioningConfiguration Walker

The hook and cable dial tensioning configuration walker shown in FIG. 26utilizes a zig-zag quick lacing structure as will be described below inorder to provide quick and comfortable simultaneous tightening of thewalker around the lower leg, ankle, and foot.

The walker 2100 of FIG. 26 utilizes a dorsal shell 2102 and a posteriorshell 2104 that complement each other in a clamshell configuration in amanner previously discussed.

In order to provide tightening of the dorsal shell 2102 to the posteriorshell 2104, a series of hooks 2108 for receiving a looped cable 2110thereon are arranged along the edges of the posterior shell 2104 suchthat the cable 2110 can be looped around the hooks to create zig-zagpattern along the dorsal surface of the dorsal shell 2102.

In order to effectuate the looping of the cable 2110 around the hooks2108, a first end of the cable 2110 is anchored at anchor point 2106 toa portion of the posterior shell 2104, for example, along the toeprotector portion. The second end of the cable is arranged to be takenup or loosened via a dial tensioner 2112 that is detachably mounted to aportion of the dorsal surface of the dorsal shell 2012, for example, theproximal portion.

With the dial tensioner 2112 detached from the walker, the cable 2110can be alternately strung between opposed hooks 2108 on opposite sidesof the posterior shell 2104. Once the cable 2110 has been strung amongall or some of the hooks 2108, the dial tensioner 2112 can be attachedto the walker and tightened in order to simultaneously tighten allportions of the walker around the lower leg, ankle, and foot.

In this configuration, a cable can be quickly laced up along the dorsalshell 2102, and quickly tightened so that the walker provides theappropriate amount of support and stability to the lower leg, ankle, andfoot.

In a variation, the cable 2110 can be looped around the posteriorportion of the posterior shell in place of, or in addition to, loopingthe cable over the hooks 2108.

Additional variations of a circumferential walker utilizing quick pulllacing structures are discussed next.

N. Detailed Description of Quick Pull Lacing Configuration Walkers

Variations of quick pull lacing configuration walkers are shown in FIGS.27 and 28.

In particular, a dorsal shell 2202 for use in a circumferential walkeris shown in FIG. 27. The dorsal shell 2202 is configured to cooperatewith a posterior shell (not shown) in a clamshell configuration aspreviously discussed

The dorsal shell 2202 includes retainers 2206 along the dorsal surfacethereof through which a cable 2210 passes. A dial tensioner (not shown)is connected with the cable 2210 in order to tighten and loosen thecable 2210 in a manner as discussed above.

The cable 2210 is loosely strung between the retainers 2206, andconnector guides 2214 are positioned along each side of the dorsal shell2202 on the cable 2210 between the retainers 2206. The connector guides2214 have optional finger loops 2216, through which a user can place afinger to grasp the connector guide 2214 for pulling the connectorguides 2214 in the directions indicated by arrow A. The finger loops2216 are provided as a convenience, since a user may simply grasp theconnector guides 2214 themselves.

Hooks 2208 are positioned adjacent to the connector guides 2214 alongthe edges of the posterior shell (not shown). Each connector guide 2214can thus be pulled in the direction A for selective engagement with arespective hook 2208. In this manner, the cable 2210 can be quick pulledand laced with the hooks 2208. Once the cable 2210 engages the hooks2208 through the connector guides 2214, the dial tensioner can beactuated in order to tighten the cable 2210 such that the dorsal andposterior shells are drawn together.

In the variation shown in FIG. 28, the walker 2200 includes a posteriorshell 2204 with multiple hooks 2208 thereon. As can be seen, the cable2210 is strung along one side of the walker (and similarly strung on theother side) through connector guides 2214, one of which corresponds totwo hook 2208 segments, the other of which corresponds to a single hook2208. Further, a finger loop 2216 is provided on the two hook spanningconnector guide, and not on the single hook connector guide. The cableis also connected to the dial tensioner 2212 for tightening andloosening in a manner previously discussed.

In this configuration, the user can more quickly quick pull lace thecable with the hooks, since multiple hooks are spanned by at least twoopposed connector guides. Thus, quick pull lacing configuration providesa method for quickly and comfortably tightening a circumferential walkeraround the lower leg, ankle, and foot.

O. Detailed Description of Variations of a Circumferential Walker

As shown in FIG. 29, a circumferential, clam-shell like walker 2600 isconfigured in a similar manner as previously discussed. The walker 2600includes a semi-rigid, or substantially rigid shell configuration aspreviously discussed.

The walker 2600 includes a posterior shell 2602 that extends from aposterior side of the lower leg and ankle, along the distal surface ofthe foot, and terminates in a toe cover portion 2608 that extends overthe toes of a wearer to protect the toes from injury. The posteriorshell 2602 includes wing portions 2604 that extend partially around thelower leg, ankle, and foot from the posterior shell 2602 to wrap aroundthe leg in order to enclose and support the leg. Connection points 2606are spaced along the wing portions 2604 for connecting a dorsal shell2610 to the posterior shell in a manner to be discussed in detail below.

The dorsal shell 2610 is correspondingly shaped to the posterior shell2602 to at least partially surround or enclose the lower leg, ankle, andfoot to provide protection, support, and stabilization thereto. Thedorsal shell 2610 is formed either in a single piece or in multipleshell portions. In the exemplary embodiment, the dorsal shell 2610includes a proximal shell portion 2612 that is connected to a distalshell portion 2614 via a hinge or other suitable connection 2616.

The ease of adjusting and tightening the circumferential walker 2600 isenhanced by the use of a rotary tightening mechanism 2618 that allowseach portion of the brace to be simultaneously incrementally tightened,without the need for numerous cumbersome straps. The tighteningmechanism 2618 is positioned in a proximal area of the dorsal shell2612, but can be positioned in any suitable location on the walker 2600.For example, while the tightening mechanism 2618 and the entire quicktightening arrangement are shown positioned along the dorsal shell, itwill be recognized that the tightening mechanism 2618 and the quicktightening arrangement can alternatively be positioned along theposterior shell 2602.

The quick tightening arrangement will now be described in detail withrespect to the configuration shown in FIG. 29. The rotary tensioningmechanism 2618 includes a main drive cable 2620 that is taken up upon aspool of the rotary tensioning mechanism 2618 via rotation of the rotarytensioning mechanism 2618 in a first direction. Rotation of the rotarytensioning mechanism 2618 in a second direction will release or unwindthe main drive cable 2620 from the spool of the rotary tensioningmechanism 2618.

The main drive cable 2620 is connected to a first tensioning pulley2622. The disclosed embodiment utilizes three tensioning pulleys 2622,but it will be recognized that more or less tensioning pulleys may beused as desired. The tensioning pulleys 2622 are spaced along theproximal and distal portions 2612, 2614 of the dorsal shell 2610. Thetensioning pulleys 2622 are mounted on an axle (not shown) fixed to thedorsal shell 2610 in a manner that will be recognized by a skilledartisan so that each tensioning pulley 2622 can rotate about the axle.

Each tensioning pulley 2622 is formed from a tensioning spool 2626 witha drive spool 2624 stacked thereon. The drive spool 2624 has a smallerdiameter than the diameter of the tensioning spool 2626, such that amechanical advantage is provided to the tensioning spool 2626 viasimultaneous rotation of the tensioning spool 2626 with the drive spool2624.

As shown in FIG. 29, the second and third tensioning pulleys 2622 arerespectively connected to the first tensioning pulley 2622 and eachother via distal drive cables 2630. The distal drive cables 2630 areconnected at a proximal end to a distal portion of the tensioning spool2626 and at a distal end to the drive spool 2624 of the adjacenttensioning pulley 2622. Each of the drive cables 2620, 2630 has apredetermined length of cable pre-wound around the drive spool 2624 ofthe tensioning pulley 2622 such that tension applied to the drive cables2620, 2630 unwinds the drive cables 2620, 2630 therefrom and rotates thedrive spool 2624, and hence the tensioning spool 2626 and the entiretensioning pulley 2622 to provide tension to the portions of the walker2600 as will be discussed in detail below.

As also shown in FIG. 29, each tensioning spool 2626 has medial-lateraltensioning cables 2628 connected at respective medial and lateral sidesof the tensioning spool 2626. The medial-lateral tensioning cables 2628are connected at a first end to the tensioning spool 2626 and at asecond end to a cable connector 2632 configured to be selectivelyengaged and disengaged with the connection points 2606 along theposterior shell 2602 in any suitable manner, such as key slot, snapfitting, hook and loop fasteners, snap fasteners, or any other suitableconnection mechanism.

As shown in FIG. 29, cable guides 2636 can be positioned along thesurface of the dorsal shell 2610 to retain the drive and tensioningcables therein to prevent binding of the cables with the components ofthe quick tightening arrangement or other objects.

As also shown in FIG. 29, tension distributors 2634 can be utilizedbetween the medial-lateral tensioning cables 2628 of adjacent tensioningpulleys 2622 to spread the tension of the cables along a greater surfaceof the posterior shell 2602 to prevent a concentration of the tension atspecific points on the posterior shell 2602. The tension distributors2634 can be a single cable spanning between adjacent tensioning pulleys2622, or can be formed from an additional cable or element spanning onlybetween the adjacent cable connectors 2632.

The structural configuration of the circumferential walker 2600 and thequick tensioning arrangement described above function in the followingmanner. Initially, the dorsal and posterior shells 2610, 2602 are eitherseparated or connected at the connection points 2606 along only alateral or medial side of the walker 2600 so that a wearer can placetheir foot, ankle, and lower leg within the posterior shell 2602 of thewalker 2600. Alternatively, enough slack in the tensioning cables can beprovided such that a wearer can place their foot, ankle, and lower legwithin the walker 2600 when the dorsal and posterior shells 2610, 2602are connected at the connection points 2606 along both the lateral andmedial sides of the walker 2600.

Once the wearer has placed their lower limb within the walker 2600, ifnot already connected, the cable connectors 2632 are connected to theconnection points 2606 on the posterior shell 2602. Once the dorsalshell 2610 is connected to the posterior shell 2602, the walker 2600 canbe quickly tightened around the lower leg, ankle, and foot, to providequick adjustment of the support and stabilization provided to the lowerleg, ankle, and foot.

As discussed above, each of the drive cables 2620, 2630 has apredetermined length of cable pre-wound about the drive spool 2624 ofthe tensioning pulley 2622. Rotation of the single rotary tensioningmechanism 2618 causes rotation of each tensioning pulley 2622 via theunwinding of the drive cables 2620, 2630 from the drive spools 2624, andthe subsequent winding of the drive cables 2620, 2630 upon thetensioning spools 2626 of the adjacent tensioning pulley. In thismanner, the single rotary tensioning mechanism 2618 can be used to applytension to the various portions of the walker 2600 simultaneously.

As each tensioning pulley 2622 is rotated by its respective drive cable2620, 2630, the tensioning spool 2626 is also rotated such that themedial-lateral tensioning cables 2628 are also wound around thetensioning spool 2626 of the respective tensioning pulleys 2622. In thismanner, the tension provided via the rotation of the single rotarytensioning mechanism 2618 is translated into simultaneous tensioning ofnumerous drive and medial-lateral cables 2620, 2630, 2628 forsimultaneous tightening and adjustment of the entire walker 2600 aboutthe lower leg, ankle, and foot. Thus, a quick and easy tighteningarrangement is provided that allows the simultaneous tightening of eachportion of the walker 2600 utilizing only a single rotary tensioningmechanism 2618 that can be positioned for easy manipulation by a wearer.

It will be recognized that when the rotary tensioning mechanism 2618 isrotated in a second direction to unwind the drive cable 2620 therefrom,the tension in the medial-lateral cables 2628 and the additional drivecables 2630 will cause the tensioning pulleys 2622 to rotate back totheir original starting position in order to release tension to thewalker 2600. Additionally, a biasing element, such as a rotary spring,can be provided to each tensioning pulley 2622 to bias the tensioningpulleys 2622 towards an initial, un-rotated position, such that arelease of tension from the main drive cable 2620 will allow thetensioning pulleys 2622 to rotate back to an original position to removethe tension from the walker 2600.

In the variation shown in FIG. 30, the quick tensioning arrangement issimilar to that shown in FIG. 29, and functions in the same manner, withthe exception that there are no tension distributors used. Theillustration of FIG. 30 more clearly shows how each drive cable 2620,2630 has a predetermined length pre-wound about the drive spool 2624.

In the variation shown in FIG. 31, which functions in the same manner asdescribed above, first, second, and third drive cables 2640, 2642, 2644are respectively connected at one end to the rotary tensioning mechanism2618 and at the other end to a respective drive spool 2624 of atensioning pulley 2622.

As with the drive cables discussed above, first, second, and third drivecables 2640, 2642, 2644 have a predetermined length wound about thedrive spool 2624 of a respective tensioning pulley 2622 such thatrotation of the rotary tightening mechanism 2618 causes the tensioningpulleys 2622 to rotate to wind the medial-lateral tensioning cables 2628thereon to provide tension to portions of the walker 2600simultaneously.

In a further variation, shown in FIG. 32, a single main drive cable 2620is connected between the rotary tightening mechanism 2618 and the drivespool 2624 of each tensioning pulley 2622. The drive cable 2620 can beanchored at one end to the most distal tensioning pulley 2622. Apredetermined length of the drive cable is then wound around the drivespool 2624 of the most distal tensioning pulley 2622. The drive cable2620 is then strung to the next tensioning pulley 2622 and apredetermined length thereof is wound around the drive spool 2624thereof. This is repeated until the second end of the drive cable 2620is connected to the rotary tightening mechanism 2618.

Rotation of the rotary tightening mechanism 2618 thus causessimultaneous rotation of each tensioning pulley 2622 via the frictionbetween the drive cable 2620 and the wound portion thereof about eachdrive spool 2624.

P. Detailed Description of Variations of Pulleys for Use with aCircumferential Walker

Variations of tensioning pulleys for use with the circumferential walkerdiscussed above are shown in FIGS. 33-37. The general function of thevariations of quick tightening arrangements are similar to thatpreviously discussed and the focus of the following discussion is on theparticular configuration of various tensioning pulleys that can be usedwith the previously described quick tightening arrangements of acircumferential walker.

A first variation of a pulley for use with the embodiments shown inFIGS. 29-31 is shown in FIG. 33. The tensioning pulley 2660 shown inFIG. 33 is formed of first and second stacked plates 2662, 2664 havingfour cable anchors 2666 positioned therebetween at opposedproximal-distal and medial-lateral positions.

For purposes of discussion, the tensioning pulley 2660 is the closestpulley to the rotary tensioning mechanism and a main drive cable 2668 ispre-wound around the four cable anchors 2666 such that rotation of therotary tensioning mechanism causes simultaneous rotation of thetensioning pulley 2660 in the manner previously discussed.

An additional drive cable 2672 is connected at a first end to the distalcable anchor 2666 and is pre-wound at a second end to an adjacenttensioning pulley 2660 in the same manner as the main drive cable 2668as just discussed for simultaneous rotation of each tensioning pulley2660 with the rotation of a rotary tensioning mechanism.

Further, medial-lateral tensioning cables 2670 are connected at a firstend to the medial and lateral cable anchors 2666 such that rotation ofthe tensioning pulley 2660 causes the medial-lateral tensioning cables2670 to be wound around the cable anchors 2666 to provide simultaneoustightening of the walker in a manner previously discussed.

The configuration of the tensioning pulley 2660 can provide a lowprofile pulley that does not include a protruding drive spool that mayinadvertently catch on objects, thus providing an improved low profilecircumferential walker.

The remaining variations of tensioning pulleys shown in FIGS. 34-37 aresuitable for use with the embodiment shown in FIG. 32, which utilizes asingle main drive cable spanning between the rotary tensioning mechanismand each adjacent tensioning spool Whereas the embodiment of FIG. 32relies solely on the friction between the drive cable and the drivespool of the tensioning pulley to provide the rotation thereof, theembodiments of FIGS. 34-37 provide a mechanism to ensure mechanicaltransfer of forces between the main drive cable and the tensioningpulleys.

For example, as shown in FIG. 34, a tensioning pulley 2650 includes amain drive cable 2652 that extends through a main drive cable guide 2654formed in the tensioning pulley 2650. The main drive cable 2652 extendsthrough the cable guide 2654 and is subsequently pre-wound about thetensioning pulley 2650 as previously discussed. Since the main drivecable 2652 extends through the cable guide 2654, as the drive cable 2652is tensioned via rotation of the rotary tensioning mechanism, the drivecable 2652 will be mechanically “locked” to the tensioning pulley 2650to cause corresponding rotation thereof.

Similarly, as shown in FIG. 35, a tensioning pulley 2680 includes firstand second spaced plates 2682, 2684 that have a main cable anchor 2686centrally positioned therein and medial-lateral cable anchors 2690positioned at medial and lateral portions thereof. A main drive cable2688 extends through, and has a predetermined length pre-wound upon, themain cable anchor 2686 to provide rotation of the tensioning pulley 2680in a manner discussed above. Medial-lateral cables 2692 are anchored tothe medial-lateral cable anchors 2690.

Similarly to the tensioning pulley shown in FIG. 34, the tensioningpulley 2680 provides a mechanical “lock” between the drive cable 2688and the tensioning pulley 2680 to ensure rotation thereof via tensioningof the drive cable 2688.

In a further variation shown in FIG. 36, a tensioning pulley 2700 has aguide slot 2704 passing therethrough to guide and retain the main drivecable 2702 therein. Medial-lateral cable anchors 2706 are providedthereon to anchor medial-lateral tensioning cables 2708. The drive cable2702 passes through the guide slot 2704 and is wound around thetensioning pulley 2700. Thus, in accordance with previously discussedvariations, a mechanical “lock” occurs between the drive cable 2702 andthe tensioning pulley 2700.

The tensioning pulley 2700 can have an oblong or elliptical shape in theproximal-distal direction to provide a mechanical advantage betweenrotation of the main drive cable 2702 and the medial-lateral tensioningcables 2708.

The variation of a tensioning pulley 2710 shown in FIG. 37 is similar tothat of the variation shown in FIG. 8 and includes a guide slot 2714passing therethrough to guide and retain the main drive cable 2712therein. Medial-lateral cable anchors 2716 are provided thereon toanchor medial-lateral tensioning cables 2718. The drive cable 2712passes through the guide slot 2714 and is wound around the tensioningpulley 2710. Thus, in accordance with previously discussed variations, amechanical “clock” occurs between the drive cable 2712 and thetensioning pulley 2710.

The tensioning pulley 2710 can have an oblong or elliptical shape in themedial-lateral direction to provide a mechanical advantage betweenrotation of the main drive cable 2712 and the medial-lateral tensioningcables 2718.

Q. Other Orthopedic Devices Having Rotary Ratcheting

The features of the aforementioned circumferential walker and thedescription in U.S. Pat. No. 7,198,610 may be extended to a variety ofother orthopedic devices.

For example, a wrist brace having a strapping system such as thosedescribed in U.S. Pat. No. 7,311,686 and U.S. patent applicationpublication 2007/0239093, incorporated by reference and commonly ownedby the assignee of this application, may include a rotary tensioningdevice. For example, a rotary ratchet of the type described in U.S. Pat.No. 7,198,610 may be combined with an individual strap such that a cableand a rotary ratchet or dial tensioner to connect to the strap to enableincremental unidirectional adjustment of the wrist brace.

In a variation, the wrist brace may be arranged with a plurality ofretainers or hooks located on opposed sides of the wrist brace panels,and a cable is laced through and about such retainers or hooks andcoupled to a dial tensioner to draw the sides of the wrist brace to oneanother. A middle panel or dorsal shell may be provided much in the samemanner as in the circumferential walker described above. The wrist bracemay be arranged similarly to the embodiments described in connectionwith at least FIGS. 13 and 20 provided herein. In another variation, theplurality of straps may be connected to one another by a cable which iscoupled to a dial tensioner, much in the form of the embodimentdescribed in connection with FIGS. 23-25 provided herein.

Another example of an orthopedic device is an ankle brace described inU.S. Pat. No. 7,311,686. The ankle brace of the U.S. Pat. No. 7,311,686may be modified in that the laces can be replaced with a dial tensionerarrangement in connection with the embodiments of FIGS. 13, 20 26provided herein. Other suitable arrangements may be used to replace thelaces and strapping of the ankle brace which are consistent with thedial tensioner embodiments described and incorporated herein.

Yet another example of an orthopedic device is a knee brace havingcircumferential or partial circumferential straps. An example of onetype of a knee brace is described in U.S. Pat. No. 7,037,287, andanother type of a knee brace is depicted in U.S. Pat. No. D558,884, bothof which are incorporated by reference herein and commonly owned by theassignee of this application. These straps may be individually connectedto a dial tensioner much in a manner described in U.S. Pat. No.7,198,610, or a series of the straps may be connected to a dialtensioner much in a manner described in FIG. 23. Similarly, otherbraces, such as elbow and back braces may include similar dial tensionerarrangements as in the knee brace.

In yet another example of an orthopedic device is a cervical collar ofthe type described in U.S. Pat. Nos. 6,254,560 and 6,921,376 which areincorporated herein by reference and commonly owned by the assignee ofthis application. In the cervical collar, a single dial tensioner may becoupled to or replace a circumferential strap or straps which retain thecervical collar on the patient. The dial tensioner can advantageouslypermit incremental adjustment at low increments to allow for gradual andsensitive adjustment of the tightness of straps or cables retaining thecollar on the patient.

In a variation of the cervical collar, one end of a strap or opposedends of a strap may be coupled to a cable connected to a dial tensioner.In another variation, the dial tensioner may be of any of the typesdescribed herein and the cervical collar can be arranged such that partsof the collar are drawn together by a plurality of cables, such as inthe embodiments of FIGS. 16, 19, 23 and 26.

R. Detailed Description of a Knee Brace

As discussed above, the embodiment of the knee brace disclosed hereinmay be of an unloading, osteoarthritic knee brace of a type generallydescribed in U.S. Pat. No. 7,198,610. Accordingly, the descriptionherein focuses on the structure, materials, and configuration of aparticular embodiment of an unloading, osteoarthritic knee brace,without belaboring the particular effects and modalities for treatingosteoarthritis in the knee joint.

Referring to FIGS. 38-42, an embodiment of an orthopedic device isillustrated in the form of a knee brace 2810 suitable for stabilizing,protecting, supporting, unloading, and/or rehabilitating the knee. Asshown, the knee brace 2810 is composed of proximal and distal shells2812, 2818 that are connected to each other via proximal and distalsupports 2826, 2828 that engage a flexion-extension hinge 2830 forrotation thereabout in a manner that will be recognized by a skilledartisan.

Suitable materials for use as proximal and distal shells 2812, 2818, theproximal and distal supports 2826, 2828, and the hinge 2830 may includeplastics, carbon or glass fiber and epoxy composites, metals, such asaluminum, or any other suitable material. It will be recognized thatdifferent materials may be used for each of the components.

As shown in FIGS. 38-42, the proximal and distal shells 2812, 2818 eachinclude a main portion that extends along the lateral side of the kneebrace 2810 and a substantially horizontally extending arcuate portionconfigured to extend around the anterior portion of the leg, and aroundthe medial side of the leg. The proximal and distal shells 2812, 2818are suitably formed of a material that provides support to the kneejoint and leg, while being flexible enough to allow the proximal anddistal shells 2812, 2818 and the horizontally extending arcuate portionsto conform to the geometry of the leg and knee joint of the user. It isunderstood that composite materials, plastics, such as polyethylene, ormetals, such as aluminum, are materials suitable to achieving supportfor the knee joint and leg while providing suitable flexibility.

In order to provide ventilation for the user when the knee brace 2810 issecured to the leg, so that perspiration may evaporate therethrough,slots or openings 2824 are defined within the proximal and distal shells2812, 2818. The slots or openings 2824 also reduce the weight of theknee brace 2810 by removing material therefrom and further impartflexibility to portions of the proximal and distal shells 2812, 2818.

In the embodiment shown in FIGS. 38-42, the proximal and distal shells2812, 2818 are overall substantially flexible to allow the shells toconform to the outline of the leg. Specifically, while the proximal anddistal shells 2812, 2818 should have a degree of toughness or rigidityto provide support to the leg and knee joint, as discussed above, theyalso are flexible enough to allow the proximal and distal shells 2812,2818 to conform to the geometry of the leg and knee joint when suitableforces are applied, for example via strapping assemblies.

Referring to FIGS. 38-42, an additional feature of the embodiment of theknee brace 2810 that provides comfort and structures for affixingstraps, as will be discussed in detail below, is the secondary, discreteregions of material integrally formed around the edges of the proximaland distal shells 2812, 2818. As previously discussed, the proximal anddistal shells 2812, 2818 each include a discrete rigid, hard, and/ortough region that essentially defines a central portion along theproximal and distal shells 2812, 2818 and that is rigid and tough enoughto provide support to the knee brace 2810 and the leg, yet still allowsthe proximal and distal shells 2812, 2818 to be substantially flexibleso as to conform to the geometry of the leg and knee joint. Each ofthese regions has a first stiffness consistent with these features.

In addition, discrete flexible and/or elastic regions 2814 and 2820generally surround, and are integrally formed with the respective mainregions of the proximal and distal shells 2812, 2818. The discreteregions 2814, 2820 are formed so as to have less stiffness than therespective main regions. In this manner, regions 2814, 2820 essentiallyprovide a compliant, pressure relieving interface between the hardermain regions and the leg and knee joint of the user. The regions 2814,2820 further may provide additional frictional engagement between theproximal and distal shells 2812, 2818 and the leg of the user, due tothe lower stiffness of the regions 2814, 2820.

The discrete regions 2814, 2820 are distinguished from the main regionsin that they preferably have a softer texture. More specifically, thediscrete regions 2814, 2820 have a hardness that is lower than thehardness of the respective main regions. The two discrete regions 2814,2820 may be integrally formed with the respective main regions using anysuitable technique, such as casting, or injection molding.

According to an exemplary embodiment, the respective main regions andthe discrete regions 2814, 2820 are formed from materials havingdifferent hardnesses. In this variation, the respective main regions andthe discrete regions 2814, 2820 are injection molded thermoplastics thatare integrally molded together. An exemplary combination of materialscomprises thermoplastic polyurethane elastomers sold under the nameELASTOLLAN by BASF group.

In making the shells 2812, 2818 of this variation, the main regions arefirst fabricated by being formed by a first mold. A first material, suchas ELASTOLLAN S60D53N, is injected into the mold so as to result in theformation of the main region of the shells 2812, 2818. The molded shells2812, 2818 are then transferred to another, larger second mold whichforms the overall finished shape of the shells 2812, 2818. The shells2812, 2818 are secured and centered in the second mold. A secondmaterial, such as ELASTOLLAN C60A10W, is injected into the second moldso as to contact the shells 2812, 2818 and form the discrete regions2814, 2820 therearound.

Due to the similarity in composition of the first and second materials,the second material of the discrete regions 2814, 2820 bond to the firstmaterial of the main regions of the shells 2812, 2818 as it is formed inthe second mold. In this variation, the first material has a hardnessthat is greater than the second material.

A significant advantage to this configuration is that the combination ofa flexible, yet tough main region with a softer region 2814, 2820surrounding and bordering the tough region of the shells 2812, 2818provides a substantially comfortable feature to the orthopedic brace.

Another advantage to this variation is that the shells 2812, 2818 andthe respective discrete regions 2814, 2820, may be pigmented indifferent colors. This results in an appearance that results in a pipingaround the periphery of the shells 2812, 2818 which provides a visuallypleasing appearance. For example, the first material used for formingthe main region of the shells 2812, 2818 may have a black pigment,whereas the second material used for forming the discrete regions 2814,2820 may have a gray pigment.

While similar materials are described in connection with this variation,it will be noted that dissimilar materials may also be used. Forexample, polyethylene, polyurethane and other thermoplastics may be usedfor forming the main region of the shells 2812, 2818, and suitablematerials such as vinyl, rubber or thermoplastic elastomers may be usedfor forming the discrete regions 2814, 2820. Other methods for formingthe main region of the shells 2812, 2818 with the discrete regions 2814,2820 may be found in U.S. Pat. Nos. 5,445,602 and 5,716,335,incorporated herein in the entirety by reference. Moreover, a softflexible region may be mechanically adhered, such as by an adhesive, toa shell having ledge, slotted or groove portions upon which the flexibleregion may be adhered and that does not interlock with any structure ofthe shell.

Additional comfort may be provided by the utilization of padding orspacer elements 2816, 2822 between the shells 2812, 2818 and the leg ofthe user. Such padding may be ventilated, with for example holes orchannels, so that perspiration may evaporate from the skin of the user.Exemplary configurations of ventilated padding are disclosed in U.S.publication no. 2006/0135900 A1 on Jun. 22, 2006, and incorporated aboveby reference.

In addition to the above described features, the proximal and distalshells 2812, 2818 each include appropriate structures for receiving andretaining straps of the device that are utilized to maintain the devicein position on the body and to provide the appropriate amount ofstability and support and/or unloading of the joint.

In particular, each of the proximal and distal shells 2812, 2818 includerespective connection points 2866, 2868 and receiving portions 2870,2872 for respectively connecting first ends 2834, 2840 of first andsecond 2832, 2838 stability straps and receiving respective second ends2836, 2842 of the first and second 2832, 2838 stability straps therein.

The connection points 2866, 2868 can be formed as slots in the discreteregions 2814, 2820 and the first ends 2834, 2840 of the first and second2832, 2838 stability straps can be looped through the slots andconnected to themselves in any suitable manner, such as by hook and loopfasteners or snap fasteners.

The receiving portions 2870, 2872 can be formed in the main regions ofthe respective shells 2812, 2818 in a shape generally corresponding tothe shape of the first and second 2832, 2838 stability straps. Thesecond ends 2836, 2842 of the first and second 2832, 2838 stabilitystraps are inserted into the respective receiving portions 2870, 2872.

In addition, the proximal shell 2812 includes first and second 2852,2854 receiving portions configured to receive respective first andsecond ends 2846, 2848 of a force strap 2844. The first and second 2852,2854 receiving portions can include indicia 2856 for indicating thetension in the force strap 2844, as will be discussed in detail below.

The distal shell 2818 also includes a retainer portion 2850 arrangedalong a proximal portion of the shell and configured for retaining amid-section of the force strap 2844 therein. While a single force strap2844 is disclosed spiraling around the knee brace 2810 and passingthrough the retainer portion 50, two distinct force straps that arerespectively anchored to the knee brace 2810 can be utilized in place ofthe single force strap 2844.

Turning again to the arrangements provided to secure the knee brace 2810to a user's leg and knee joint, first and second stability straps 2832,2838 connect to the proximal and distal shells 2812, 2818 in a mannerproviding much versatility for accommodating many variable geometries ofleg and knee joints, and in a quick tensioning manner. The stabilitystraps 2832, 2838 are utilized to secure the proximal and distal shellsto the thigh and calf portions of the leg by wrapping around therespective leg portions. The stability straps 2832, 2838 may be formedfrom any suitable material, such as plastic, so as to be flexible enoughto wrap around and configure to the geometry of the leg and knee joint.The stability straps 2832, 2838 may be formed in any known suitablemanner, such as casting or injection molding. Each of the stabilitystraps 2832, 2838 may include a cushion feature, such as foam or atextile pad that is secured thereon for enhanced rotational preventionand additional comfort. Of course, the cushion feature may be anysuitable pad, such as a ventilated pad of the type previously discussed.

As best seen in FIG. 41, and as described above, the first ends of thestability straps are connected to the shells in a manner that allows thestability straps to be selectively connected or disconnected. The firstends of the stability straps can be looped through a slot in thediscrete regions of the shells (or in the shells themselves) andconnected to the straps themselves via suitable mechanisms, such as hookand loop or snap fasteners. Thus, the stability straps can be adjusted.The straps can further be adjusted utilizing pull tightening mechanisms2874, 2876.

As best seen in FIGS. 40 and 42, pull tightening mechanisms 2874, 2876are engaged with the second ends 2836, 2842 of the stability straps viaend connectors (hidden from view, see end connectors 2858, 2860described below) and a cable or lace 2864. The cable 2864 is fed throughrespective release mechanisms 2882, 2884 and connected with respectivepull tabs 2878, 2880.

The release mechanisms 2882, 2884 may include a locking element thatallows the cable 2864 to be pulled through the mechanism in a firstdirection when the release mechanism is engaged, but does not allow thecable 2864 to be pulled back through the release mechanism. Whenpressure is applied to the button of the respective release mechanisms2882, 2884, the locking element will be disengaged and the cable 2864may be pulled back through the pull tightening mechanisms 2874, 2876. Inthis manner, the tension in the stability straps 2832, 2838 can bequickly and easily adjusted by pulling the respective pull tabs 2878,2880.

In an alternative configuration, the looped first ends 2834, 2840 of thestability straps 2832, 2838 can be permanently secured to the strapsthemselves, and adjustment of the straps can be provided solely via thepull tightening mechanisms 2874, 2876.

Turning now to the force strap 2844, the first and second ends 2846,2848 of the force strap 2844 are respectively received within the firstand second receiving portions 2852, 2854 arranged along the distalportion of the proximal shell 2812. As previously stated, the forcestrap 2844 is spirally wound around the leg and knee brace 2810, andpasses through the force strap retainer 2850 formed along the proximalportion of the distal shell 2818. The force strap 2844 is utilized toprovide desired stability and support, and/or unloading of the joint.

The first and second ends 2846, 2848 of the force strap 2844 are eachrespectively connected via an end connector 2858, 2860 to a respectivecable 2864. Each of the respective cables 2864 is further connected to adial tensioning mechanism 2862 that can be manipulated in a firstdirection to tension the force strap 2844 or a second direction toloosen the force strap 2844.

The first and second ends 2846, 2848 of the force strap 2844 are visiblethrough slots in the receiving portions 2852, 2854. The indicia 2856 arearranged along the slots, such that the marker that corresponds to theposition of the first and second ends 2846, 2848 of the force strap 2844indicates the amount of tension in the force strap.

As can be seen, once a user positions their leg within the knee brace2810, the stability and force straps can be quickly and easily adjustedto provide the proper amount of strap tension in order to achieve thedesired amount of support and stabilization, and/or unloading of thejoint. Thus, the knee brace 2810 can be easily adjusted by all users,and in particular the infirm and elderly

In view of the above description, an exemplary embodiment of alightweight, low cost, versatile and easily adjustable brace with quickstrap tensioning is described.

S. Conclusion

The disclosed embodiments of orthopedic devices and particularly acircumferential walker provide many improvements and allow easyinsertion or removal of the lower leg into the walker. Additionally, thetightening mechanisms allow quick and easy tightening of the walkeraround the lower leg in order to provide the necessary support andstabilization of the lower leg. Accordingly, the disclosed embodimentsof a circumferential walker are easier to don and doff, which will beadvantageous to numerous users, including the elderly or infirm.

While particular embodiments of orthopedic devices are discussed aboveutilizing certain parts and materials, the components of the devicesdescribed herein may be formed in any suitable manner recognized by askilled artisan, such as casting, machining, stereolithography, or anyother suitable process.

One of the disclosed embodiments of an orthopedic device provides animproved knee brace that is lightweight and low cost and has a lowerprofile than a typical brace, and provides quick strap tensioning suchthat all users can easily adjust the brace for proper fit, support,stabilization, and/or unloading of the joint.

It is understood that the size of the disclosed embodiments and thecomponents thereof can be adjusted so that different users havingdifferent sized knees, legs, ankles, and feet may benefit from thepresent design. Specifically, the width, thickness and length of theshells and sole members may be varied to accommodate different sizedusers.

It is also understood that the locations of the various components andconnection points can be alternated from those shown, such that theconnection points may be altered from the positions as illustratedherein.

Of course, it is to be understood that not necessarily all objects oradvantages may be achieved in accordance with any particular embodimentof the invention. Thus, for example, those skilled in the art willrecognize that the invention may be embodied or carried out in a mannerthat achieves or optimizes one advantage or group of advantages astaught herein without necessarily achieving other objects or advantagesas may be taught or suggested herein.

The skilled artisan will recognize the interchangeability of variousdisclosed features from different embodiments. For example differentconnecting mechanisms may be freely changed and substituted.Additionally, any suitable tightening mechanism may be utilized, such aslacing or hook and loop strap fasteners. Further, each of the dorsalshell configurations may be applied to a posterior shell configuration,and vice versa. In addition to the variations described herein, otherknown equivalents for each feature can be mixed and matched by one ofordinary skill in this art to construct a circumferential walker inaccordance with principles of the present invention.

Although this invention has been disclosed in the context of certainexemplary embodiments and examples, it therefore will be understood bythose skilled in the art that the present invention extends beyond thespecifically disclosed embodiments to other alternative embodimentsand/or uses of the invention and obvious modifications and equivalentsthereof. Thus, it is intended that the scope of the present inventionherein disclosed should not be limited by the particular disclosedembodiments described above.

1. An orthopedic device comprising: a first member contoured togenerally correspond to an anatomical limb; a second member contoured togenerally correspond to an anatomical limb and to complement the firstmember and moveable with respect to the first member to provide accessto an interior space defined between the first and second members; and atightening mechanism including a dial tensioning device for connectingand for simultaneously and incrementally drawing the second membertowards the first member, thereby limiting access to the interior space.2. The orthopedic device according to claim 1, wherein the dialtensioning device is positioned on the second member and is arranged totake up a cable; and the cable is carried on the second member forselective engagement with the first member.
 3. The orthopedic deviceaccording to claim 2, wherein the cable is wound along a surface of thesecond member and loops of the wound cable selectively engage respectiveretainers on the first member.
 4. The orthopedic device according toclaim 3, wherein at least one of the loops of wound cable passes througha connector guide that selectively engages a retainer on the firstmember; and wherein a finger loop is provided on the connector guide toaid with manipulating the connector guide.
 5. The orthopedic deviceaccording to claim 2, wherein the cable is wound along a surface of thesecond member and loops of the wound cable pass through retainersconfigured for selective engagement with respective receiver portions onthe first member.
 6. The orthopedic device according to claim 1, whereinthe dial tensioning device is positioned on the first member and isarranged to take up a cable strung between retainers positioned on thefirst and second members.
 7. The orthopedic device according to claim 6,wherein the second member has two parts that are configured to beselectively connected together.
 8. The orthopedic device according toclaim 1, wherein the second member includes connectors configured forselective engagement with receiver portions on the first member.
 9. Theorthopedic device according to claim 8, wherein the second member has atleast two parts that are relatively movable with respect to each other.10. The orthopedic device according to claim 1, wherein the tighteningmechanism further includes at least one tensioning pulley; a drive cablestrung between the dial tensioning device and the tensioning pulley; andat least one medial-lateral tensioning cable extending between thetensioning pulley and the first member, such that rotation of the rotarytensioning mechanism in a first direction causes rotation of the atleast one tensioning pulley to cause the at least one medial-lateraltensioning cable to draw the first and second members together.
 11. Anorthopedic device comprising: a flexible or rigid frame member contouredto generally correspond to an anatomical limb; a strapping systemincluding a dial tensioning device and at least one strap connected tothe dial tensioning device, the dial tensioning device comprising arotary ratchet permitting incremental adjustment of the at least onestrap; wherein adjustment of the dial tensioner in a first directionurges the flexible frame member to bend about an anatomical limb and/orsecures the flexible and/or rigid frame member to the limb.
 12. Theorthopedic device according to claim 11 further comprising: a secondflexible or rigid frame member contoured to generally correspond to ananatomical limb; and at least a second strap connected to the dialtensioning device; wherein the dial tensioning device is arranged forselective engagement with the second flexible or rigid frame member andadjustment of the dial tensioner in a first direction urges both of theflexible frame members to bend about an anatomical limb and/or securesboth of the flexible and/or rigid frame members to the limb
 13. Theorthopedic device according to claim 12 wherein the straps are connectedto the dial tensioning device via at least one cable, the rotary ratchetpermitting incremental adjustment of the straps by winding the at leastone cable; and wherein adjustment of the dial tensioner in a firstdirection secures the straps to the frame member and to the limb. 14.The orthopedic device according to claim 11 further comprising: a secondstrap connected to a second dial tensioning device, the second dialtensioning device comprising a rotary ratchet permitting incrementaladjustment of the second strap; wherein adjustment of the second dialtensioner in a first direction urges the flexible frame member to bendabout an anatomical limb and/or secures the flexible and/or rigid framemember to the limb.
 15. An orthopedic device comprising: a proximalshell; a distal shell moveably connected to the proximal shell; at leastone stability strap connected at first and second ends to either theproximal or distal shell; a pull tab connected to one end of the atleast one stability strap for providing tensioning of the at least onestability strap.
 16. The orthopedic device according to claim 15 furthercomprising: a force strap passing through a retaining portion on thedistal shell and having first and second ends connected to a mechanismfor providing tensioning of the force strap.
 17. The orthopedic deviceaccording to claim 16, wherein the first and second ends of the forcestrap are connected to a dial tensioning device wherein adjustment ofthe dial tensioner in a first direction tightens the force strap. 18.The orthopedic device according to claim 17 further comprising: firstand second receiving portions on the proximal shell; indicia on thefirst and second receiving portions corresponding to a tension in theforce strap; and wherein the first and second ends of the force strappass through the respective first and second receiving portions on theproximal shell and adjustment of the dial tensioner in a first directiontightens the force strap such that the tension in the force strap isindicated by the indicia.
 19. The orthopedic device according to claim15 wherein the pull tab is connected by a cable to the one end of the atleast one stability strap and the cable passes through a lockingmechanism.
 20. The orthopedic device according to claim 19, wherein thelocking mechanism includes a push button release.